1. Field of the Invention
The present invention relates generally to combating influenza and, more particularly, to using a nose and throat anti-influenza solution to decrease the likelihood influenza infection and its spread.
2. Description of the Prior Art
The common flu is an illness caused by viruses known as influenza. The influenza virus infects the respiratory tract. Compared with most other viral respiratory infections, such as the common cold, influenza (flu) infection often causes a more severe illness. Every year millions of people die from this virus around the world. The virus spreads so easily that tens of millions of people catch it each year. It mutates so fast that no one ever becomes fully immune. New vaccines are needed each year. Even today with all of our advances in medicine and technology and all of our history with this virus there is no known cure. In fact we are not sure how to prevent its spread. The virus has an impact on all aspects of our economy and life.
A new strain of influenza virus known as H5N1, also known as the avian or bird flu has caused growing concerns. The World Health Organization (WHO) is monitoring the virus closely as occurrences of infection continue.
Two differing opinions regarding this strain have been shared since the virus began being reported. Some experts believe it is just a matter of time before an influenza pandemic hits and avian or bird flu (H5N1) may be the strain that causes the pandemic. Some experts believe we are better suited concentrating our efforts on solving current known diseases, other viruses and pandemics. However if it is not H5N1, there will be another influenza strain of utmost concern.
World estimates are that 9 million people will die from this next pandemic. In the United States, the estimates are approximately 500,000 people will die. Based upon the current population census and the mortality rate of the 1918 virus, if the virus hit today we could experience one “silent killer” that creates more deaths in a few short weeks than the annual number of deaths for heart disease, stroke, chronic pulmonary disease, AIDs, Alzheimer's and all cancers combined.
The avian or bird flu is due to an influenza virus. Influenza is defined as:                1. An acute contagious viral infection characterized by inflammation of the respiratory tract and by fever, chills, muscular pain, and prostration. Also called grippe; or        2. Any of various viral infections of domestic animals characterized generally by fever and respiratory involvement.        
The influenza virus has two distinct surface proteins called HA or hemagglutinin, and NA or neuraminidase or H and N for short. In addition to coating the virus they provide important functions for infecting the cells and replication. Each virus has exactly one H and one N type of protein. The field of virology has isolated 15 types of the H and 9 types of the N. Each virus is named for the particular type of H and N that it has. For example the Spanish Flu of 1918 was a H1N1 virus. The current avian virus is H5N1. The virus is a member of a family of viruses called the orthomyxoviruses.
The virus is approximately 150 nm long and with a shape that can vary from a spheroid to cylindrical. It has several layers. The outer layer is like a cell wall and is similar to the cell wall of ordinary cells. This is composed of a lipid bilayer membrane with embedded proteins. This offers a general form of protection for the virus. The second layer is felt to be a firmer and hardened shell. It is composed of proteins which are thought to protect the viral RNA genes. Additionally, the proteins in this second layer connect to and integrate with the outer lipid layer.
The virus gains access to a human cell by contact with its surface. The H or hemagglutinin will bind to receptors present on the cell surface. Receptor binding is via multiple low affinity receptors and it is felt that when sufficient binding strength is achieved, the virus enters the cell in a process called endocytosis. The entry vesicle, called an endosome, is transported inside the cell to an area near the nucleus. The virus fuses with the lipid wall of the endosome and eventually, the viral contents including RNA is spilt into the cell cytoplasm. The RNA is transported to the nucleus. The cell is then instructed to follow the instructions in the viral genes. At that point the cell synthesizes more viruses and the viruses then reassemble and are released from the cell in large numbers.
The avian virus has been with the world for quite some time and probably as long as man and bird have been on the planet. Studies of the Avian Flu of 1918 have shown that the virus had an avian origin and this was confirmed in three separate isolates of the virus. One was from a woman frozen on the Alaskan Tundra. There have been four pandemics since 1917 and some have happened despite regular influenza vaccinations of the world populations. Birds like humans can easily pass viruses to each other. In 1997 a strain of virus appeared in the bird population that was particularly deadly. However, the strain was not deadly in ducks, which can carry the virus in their lungs and intestines without symptoms. Because of the deadly nature of the virus and the rapid spread in poultry and wild-birds, the total number of avian virus world-wide is increasing dramatically. It is known that viruses adapt through mutation and recombination, therefore as viral mutations and recombinations continue, the viral strains become more efficient and adaptable. Eventually a human strain that retains the deadly nature of the avian flu (H5N1) will appear. This will likely lead to a pandemic.
Respiratory strains of influenza are the most troublesome because of the high potential for its transmission in mucus and bodily fluids. When people sneeze and/or cough, they are potentially spreading the virus. The virus infects through the respiratory tract, including the nasal cavity and the back of the throat, areas where there are mucous membranes and mucus that can be spread by sneezing and/or coughing.
Typical attempts to fight influenza use vaccines. Unfortunately this does not attack the viruses at their primary entrance and exit from the human body, the nose and throat. Further, new vaccines are needed for new strains of the virus and are not easily scalable. Each year, vaccines are only created for a handful of flu strains, leaving people without comprehensive influenza protection; there would be an estimated six month delay to create a vaccine in response to a pandemic.
Other attempts to fight influenza have used M2 blockers and neuraminidase inhibitors (e.g. Tamiflu® and Relenza®). Unfortunately, flu strains H3N2 and H1N1 in Asia have already shown resistance to M2 blockers. Resistance is also rising against the neuraminidase inhibitors. Additionally neuraminidase inhibitors have other issues such as: limited efficacy; high cost and relatedly, dosage needs are increasing; and side effects such as hysteria and psychiatric symptoms. For instance, consider oseltamivir, a neuraminidase inhibitor. The mortality of oseltamivir treated patients worldwide for the current stain of Avian Influenza H5N1 is close to 50%. There is evidence from animal studies that the current dosage used to treat influenza and Avian Influenza in particular of 75 mg twice daily is too small and should be increased 2 to 10 fold. In general for ordinary human influenza such as H3N2, treatment must begin within 6 to 24 hours of onset of symptoms in order for it to be effective. There are reports of serious neuropsychiatric symptoms from oseltamivir in Japan including suicide attempts.
Thus, there is a need for a scalable, safe, multi-faceted anti-influenza solution that can be applied topically to the nose, throat, and respiratory tract that has good efficacy against all strains of the virus and that is not easily resisted by future mutations of influenza strains.